Recall Z-1127-2012 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system
| Date | Feb 29, 2012 (initiated Jan 20, 2012) |
| Status | Terminated |
| Reason | There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where data in Short-Term Storage (STS) could reaming unprotected and not archived. this can happen when an archive server with a USB dongle-based license is enabled with auto archiving. If the disk fill level is reached which triggers auto deleti |
| Root cause | Software design |
| Action | Siemens sent a Customer Safety Advisory Notice letter dated January 20, 2012 to all affected consignees. The letter identified the affected product, problem, steps to take to avoid this issue, and actions to be taken. Customers were instructed to contact their local Siemens Service to plan for their software update and ensure that this safety advisory is placed in the system's instruction for use. |
| Quantity | 7 |
| Distribution | Nationwide Distribution (USA) - CA, FL, GA, MO, NY and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093612 | SYNGO.PLAZA Siemens AG Medical Solutions, Mar 4, 2010 |